Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215025
Company: MAIA PHARMS INC
Company: MAIA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (2GM/20ML;2GM/20ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/10/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215025s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215025Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215025Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/10/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215025s000lbl.pdf |
SODIUM PHENYLACETATE AND SODIUM BENZOATE
SOLUTION;INTRAVENOUS; 10%;10% (2GM/20ML;2GM/20ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (2GM/20ML;2GM/20ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 215025 | MAIA PHARMS INC |